EP2629712B1 - Implants intragastriques remplisseurs d'espace à écoulement de fluide - Google Patents

Implants intragastriques remplisseurs d'espace à écoulement de fluide Download PDF

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Publication number
EP2629712B1
EP2629712B1 EP11773973.0A EP11773973A EP2629712B1 EP 2629712 B1 EP2629712 B1 EP 2629712B1 EP 11773973 A EP11773973 A EP 11773973A EP 2629712 B1 EP2629712 B1 EP 2629712B1
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EP
European Patent Office
Prior art keywords
stomach
implant
chambers
flow channel
balloon
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP11773973.0A
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German (de)
English (en)
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EP2629712A2 (fr
Inventor
Mitchell H. Babkes
Zachary P. Dominguez
Justin J. Schwab
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Apollo Endosurgery Inc
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Apollo Endosurgery Inc
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Priority to EP16180129.5A priority Critical patent/EP3111898A1/fr
Publication of EP2629712A2 publication Critical patent/EP2629712A2/fr
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Publication of EP2629712B1 publication Critical patent/EP2629712B1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/003—Implantable devices or invasive measures inflatable
    • A61F5/0033—Implantable devices or invasive measures inflatable with more than one chamber
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/003—Implantable devices or invasive measures inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0036—Intragastrical devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0083—Reducing the size of the stomach, e.g. gastroplasty
    • A61F5/0086—Reducing the size of the stomach, e.g. gastroplasty using clamps, folding means or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A61F5/0079—Pyloric or esophageal obstructions

Definitions

  • the present invention is directed to intragastric implants used for the treatment of obesity, and in particular to implants and systems for placement in the stomach cavity that take up space and provide alternative flow paths.
  • Obesity is caused by a wide range of factors including genetics, metabolic disorders, physical and psychological issues, lifestyle, and poor nutrition. Millions of obese and overweight individuals first turn to diet, fitness and medication to lose weight; however, these efforts alone are often not enough to keep weight at a level that is optimal for good health. Surgery is another increasingly viable alternative for those with a Body Mass Index (BMI) of greater than 40. In fact, the number of bariatric surgeries in the United States was estimated to be about 400,000 in 2010.
  • Examples of surgical methods and devices used to treat obesity include the LAP-BAND® (Allergan Medical of Irvine, CA) gastric band and the LAP-BAND AP® (Allergan).
  • LAP-BAND® Allergan Medical of Irvine, CA
  • LAP-BAND AP® Allergan
  • surgery might not be an option for every obese individual; for certain patients, non-surgical therapies or minimal-surgery options are more effective or appropriate.
  • intragastric balloons In the early 1980s, physicians began to experiment with the placement of intragastric balloons to reduce the size of the stomach reservoir, and consequently its capacity for food. Once deployed in the stomach, the balloon helps to trigger a sensation of fullness and a decreased feeling of hunger.
  • These devices are designed to provide therapy for moderately obese individuals who need to shed pounds in preparation for surgery, or as part of a dietary or behavioral modification program.
  • These balloons are typically cylindrical or pear-shaped, generally range in size from 200-500 ml or more, are made of an elastomer such as silicone, polyurethane, or latex, and are filled with air, an inert gas, water, or saline.
  • the BIB System comprises a silicone elastomer intragastric balloon that is inserted into the stomach and filled with fluid. Conventionally, the balloons are placed in the stomach in an empty or deflated state and thereafter filled (fully or partially) with a suitable fluid. The balloon occupies space in the stomach, thereby leaving less room available for food and creating a feeling of satiety for the patient. Placement of the intragastric balloon is non-surgical, trans-oral, usually requiring no more than 20-30 minutes.
  • the procedure is performed gastroscopically in an outpatient setting, typically using local anesthesia and sedation. Placement of such balloons is temporary, and such balloons are typically removed after about six months. Removing the balloon requires deflation by puncturing with a gastroscopic instrument, and either aspirating the contents of the balloon and removing it, or allowing the fluid to pass into the patient's stomach. Clinical results with these devices show that for many obese patients, the intragastric balloons significantly help to control appetite and accomplish weight loss.
  • Some attempted solutions for weight loss by placing devices in the stomach result in unintended consequences. For instance, some devices tend to cause food and liquid to back up in the stomach, leading to symptoms of gastroesophageal reflux disease (GERD), a condition in which the stomach contents (food or liquid) leak backwards from the stomach into the esophagus. Also, the stomach acclimates to some gastric implant devices, leading to an expansion of stomach volume and consequent reduction in the efficacy of the device.
  • GFD gastroesophageal reflux disease
  • US 2010/0168782 A1 discloses an intragastric device comprising a flexible and expandable bladder having a predetermined shape upon expansion for contacting the antrum of the stomach of a subject.
  • the device is designed to avoid passage of any part of the device beyond the pylorus and lower esophageal sphincter while the bladder is expanded during use.
  • the bladder can contain a high specific gravity material when expanded; wherein, the high specific gravity material contributes to an in vivo specific gravity of the device that ranges from about 1.2 g/ml to about 2.1 g/ml and functions to direct the device to the pyloric antrum of the subject during use of the device.
  • the device can include a filling material comprising a biocompatible fluid component and a hydrogel component to make the device substantially leakproof and contribute to the in vivo specific gravity of the device.
  • US 2007/0100368 A1 discloses a gastric space filler device for treating obesity in a patient by reducing the stomach volume comprising an inflatable space filler and a safety element secured to the space filler, wherein the safety element yields a noticeable signal for causing removal of the space filler.
  • US 2007/0083224 A1 discloses a gastric bariatric balloon includes an upper balloon chamber for sealing against the fundus, a lower balloon chamber for sealing against the antrum and occupying the body of the stomach, and a supplementary chamber for filling at least a portion of the fundus.
  • a tubular inlet is proximal the esophagus entry for receiving a hollow needle. This inlet is filled with a self-sealing material so that when punctured by the needle the material closes the needle hole upon withdrawal of the needle. Spaced apart voids in the material enable fluid interchange between the needle and each of the three chambers separately depending upon the depth of the needle within the inlet tube.
  • Safety arms are mounted on the upper balloon chamber so as to prevent passage of the balloon through the pylorus in case of sudden deflation.
  • the present invention addresses the above-described problems by providing passive intragastric apparatuses according to claim 1.
  • passive devices do not autonomously change shape, but instead react within the stomach to induce satiety.
  • the devices may take up volume within the stomach, thus reducing the intake capacity.
  • the devices may contact areas within the stomach, such as the cardia surrounding the esophageal sphincter, to stimulate satiety-inducing nerves.
  • certain devices slow gastric emptying by blocking or otherwise impeding flow through the pyloric sphincter.
  • Methods of implant are disclosed including compressing the devices within a delivery tube and transorally advancing the devices through the esophagus to be deployed within the stomach. Removal of the devices occurs in the reverse.
  • a passive intragastric obesity treatment implant disclosed herein comprises an inflatable body having a length sufficient to extend between the esophageal sphincter and the pyloric sphincter upon implant in the stomach, and a width sufficient to contact the interior stomach walls upon contraction thereof.
  • the body is rounded and slightly tapered so as to generally conform to the volume of an adult stomach cavity.
  • the body further includes a plurality of or a series of chambers fluidly connected so as to be capable of simultaneous inflation and deflation.
  • the implant is formed of a material which permits it to be compressed into a substantially linear delivery configuration and that will resist degradation over a period of at least six months within the stomach.
  • the central flow channel desirably has a star-shaped cross-section.
  • the implant further may include a plurality of circumferential grooves extending around the body and between adjacent chambers, and radial passages connecting the circumferential grooves to the central flow channel.
  • the chambers preferably gradually decrease in diameter from the superior to the inferior ends of the body.
  • the body may have a rounded superior end that mimics the shape of the surrounding cardia and defines a proximal chamber therein. permits it to be compressed into a substantially linear delivery configuration and that will resist degradation over a period of at least six months within the stomach.
  • the body has an ear-horn shape narrowing from the bowl-shaped proximal end along the leg to the pyloric member.
  • the leg includes a plurality of large apertures to permit ingress of stomach juices to the interior of the leg.
  • the body may be inflatable, and the stoma opening communicates with a flow-through passage that extends to the outside of the leg.
  • a hollow flexible tether has a lumen and a length sufficient to extend substantially the entire length of the stomach cavity from the pyloris to the esophageal/stomach junction and for a distance into the esophagus.
  • a detention tray affixes to a proximal section of the tether and has a size that impedes free passage of food boluses entering the stomach from the esophagus.
  • a series of inflatable balloons are affixed to the tether and are in fluid communication with the lumen so as to be able to receive fluid from and be filled by fluid in the tether.
  • the inflatable balloons include a pyloric balloon at a distal end of the tether having a size that will not pass through the pyloric sphincter. Further, the detention tray is positioned on the tether relative to the pyloric balloon so as to be located adjacent the cardia.
  • the implant is made of a material that will resist degradation over a period of at least six months within the stomach.
  • the detention tray is preferably non-inflatable.
  • the detention tray is bowl-shaped with a concave proximal side.
  • One of the inflatable balloons may be a positioning balloon sized larger than the others and positioned on the tether just distal to the detention tray so that it contacts the surrounding cardia and centers the tether and tray below the esophageal/stomach junction.
  • the positioning balloon may have an arcuate outer section connected by spokes to a middle portion through which the tether passes, and the outer section may define a full circle.
  • the pyloric balloon is desirably shaped like a donut with a central through hole that permits passage of chyme from the stomach to the pyloric sphincter.
  • the inflatable balloons further may include the pyloric balloon and a pair of spherical intermediate balloons between the pyloric balloon and the detention tray, the intermediate balloons maintaining a space between the tether and the stomach wall.
  • the implant may
  • the present invention is directed to a variety of different intragastric devices that passively treat obesity by taking up space within the stomach or contact areas in and around the stomach to induce feelings of satiety. Furthermore, some devices described herein affect the rate of stomach emptying. It should be understood that a number of the disclosed devices provide more than one of these passive aspects, and also that any disclosed structure could be combined with another disclosed structure unless physically impossible. As such, combinations of the passive satiety-inducing features disclosed herein, even if not explicitly stated, are contemplated.
  • the term "passive” refers primarily to a lack of any moving parts within the devices, but in general to the inert nature of the various devices. A passive device as defined herein, however, is not one that cannot affect change or stimulate the stomach, but rather one that may do so without any physical or chemical changes to its basic makeup.
  • Figure 1 illustrates a first space-occupying device 160, but also illustrates the anatomy of the human stomach, which will be described first.
  • the major function of the stomach is to temporarily store food and release it slowly into the duodenum.
  • the esophagus extending downward from the mouth connects to the stomach via esophageal sphincter, which regulates flow food into the stomach cavity.
  • the cardia surrounds the superior opening of the stomach.
  • the rounded portion superior to the body and adjacent the cardia is the fundus.
  • Inferior to the fundus is the large central portion of the stomach, called the body, that is lined with muscles that contract and relax repetitively to churn the food therein.
  • the stomach processes the food to a semi-solid "chyme," which enables better contact with the mucous membrane of the intestines, thereby facilitating absorption of nutrients.
  • the stomach is an important site of enzyme production.
  • the antrum connects the body to the pyloris, which leads into the duodenum.
  • the duodenum leads into the upper part of the small intestine (not shown); the jejunum makes up about one-third of the small intestine.
  • the region of the stomach that connects to the duodenum is the pylorus.
  • the pylorus communicates with the duodenum of the small intestine via the pyloric sphincter (valve). This valve regulates the passage of chyme from stomach to duodenum and it prevents backflow of chyme from duodenum to stomach.
  • a stomach-in-stomach device 160 shown in Figures 1-3 includes an inflated soft body 161 that conforms to the stomach and is generally convex.
  • the device 160 has a rounded superior end 162 that abuts the cardia, an annular recess 163 adjacent thereto, and a gradually tapered and curved inferior portion that conforms to the greater curvature of the stomach and terminates in a scalloped inferior end 164.
  • the inflated body 161 seen in longitudinal section within the stomach in Figure 2 comprises a series of chambers 166 fluidly connected so as to be capable of simultaneous inflation and deflation.
  • the body 161 has three annular chambers 166 delimited by exterior circumferential grooves 167 and surrounding an inner generally longitudinal flow channel 168.
  • the three chambers 166 gradually decrease in diameter from the superior to the inferior end of the device 160.
  • the flow channel 168 extends from the annular recess 163 to the inferior end 164.
  • a series of apertures 169 open the inner channel 168 to the annular recess 163 near the superior end 162.
  • Radial passages 170 extend between the circumferential grooves 167 and the inner flow channel 168.
  • the device 160 is a saline-filled, soft, balloon-like structure shown in a pre-implant state in Figure 3 , which occupies and conforms to the entire stomach cavity. Once implanted and inflated, the device 160 assumes an arcuate path as it conforms to the stomach cavity, as in Figures 1 and 2 . Due to the device size, available stomach volume is drastically reduced, so volume in which food mass may reside is far less than normal, and a feeling of satiety will occur sooner. As seen by the dashed-line arrow in Figure 2 , solid and liquid matter enters the annular recess 163 from the esophagus and passes inward to the inner channel 168 through the apertures 169.
  • the inner flow channel 168 through the center connects the upper stomach to the lower, without obstruction of the pylorus and subsequent delayed gastric emptying.
  • the flow channel 168 has a star-like cross sectional shape such that peristaltic action of the stomach walls (inward arrows shown in Figure 2 ) will transfer through to the "sharp-walled" center channel, via hydraulic compression, and the mechanical action upon the food will be improved as compared to a round channel.
  • the central flow channel 168 acts as a smaller than normal stomach, so food intake cannot be as great as before device placement.
  • the grooves 167 in the outside walls of the device 160 help channel small solids and liquids to the smaller passages 170 that radiate toward the larger, central channel 168. Smaller particles and some liquids may pass directly into the pylorus through the scalloped atrium end 164 of the channel 168.
  • the rounded superior end 162 of the device 160 presses against cardia, thereby triggering release of satiety-inducing hormones, signaling the body to stop eating.
  • the inflated device substantially fills the stomach cavity which maintains contact with the cardia.
  • the churning of the stomach walls will naturally squeeze the device 160, such that the superior end 162 will pressurize and apply greater force to the cardia.
  • a lubricated, Teflon or similar material, thin-walled tube would be inserted down the esophagus, and partially into the stomach, with the device compressed and pre-loaded inside the tube. Then the device would be maintained in its location by using a foot-ended wire or similar obturator, to bear on the compressed mass, and the delivery tube would be pulled back up the esophagus, and extracted through the mouth, leaving the device in place. While the tube is removed, the resiliency of the material causes the device to "spring open" to its original/non-compressed shape.
  • a valve (not shown) near the superior end may be provided for saline filling the body 161.
  • a lubricated tube 172 extends down through the esophageal sphincter and into proximity with the superior end 162.
  • a wire or other device is used to deflate the body 161, and the saline simply drains into the stomach.
  • a grabber 174 passed down the removal tube 172 then grabs the superior end of the body 161 and pulls the device 160 into the tube. Because of the extremely soft and flexible material used, such as certain fluoroelastomers, the device 160 collapses easily into the tube 172.
  • FIG. 5-8 Another device 180 that has a flow-through channel and almost-entirely fills the stomach is shown in Figures 5-8 .
  • This device 180 occupies volume within the stomach; however, its main mode of action is the ability to exert pressure on the stomach walls in order to induce feelings of fullness.
  • the device 180 consists of a collapsible tubular stent 182 surrounded by a generally annular foam body 184, and is seen pre-implant in Figures 5 and 5A .
  • the stent 182 provides a filtered pathway for food in the stomach to pass, which should limit the likelihood of gastroesophageal reflux disease (GERD). While providing some rigid structure to the device 180, the stent 182 is also compliant enough in the radial direction to both facilitate implantation/explantation and accommodate stomach contractions.
  • GSD gastroesophageal reflux disease
  • the stent 182 is normally expanded, but can be compressed to a size that allows for insertion and removal through a tube 185 passed through the esophagus, as seen in Figure 6 .
  • a proximal end of the stent 182 is equipped with a ring 186 as seen in Figures 7A/7B that allows for either a custom or standard endoscopic tool to pull the stent into a sheath which collapses the structure.
  • the stent 182 has a tubular wall 188 formed of a latticework of interconnected struts that permit radially compression and expansion.
  • a web of angled struts 190 on the proximal end extend inward from the wall 188 and are joined together by the ring 186.
  • the angled struts 190 act as a filter for larger solid particles which helps slow stomach emptying and may encourage a feeling of satiety if the proximal end of the device 180 is positioned close to the cardia. In contrast to some other prior intragastric implants, the continually open passageway through the device 180 helps prevent GERD.
  • the stent 182 may be made from materials including (but not limited to) rubbers, fluorosilicones, fluoroelastomers, thermoplastic elastomers, thermoplastics, thermosets, metals, or any combinations thereof.
  • the sponge like, foam body 184 (open or closed cell) surrounding the stent 182 fills the space across the stomach cavity, though does not extend the full length of the stomach, as seen in Figure 8 .
  • the axial dimension of the foam body 184 is between about 10-20 cm.
  • the foam body 184 in its relaxed, uncompressed configuration as seen in Figure 5 has a cylindrical outer surface 192, a cylindrical inner bore 194 that closely receives the stent 182, and outwardly-projecting conical end surfaces 196.
  • the foam body 184 conforms to the shape of the stomach cavity when implanted, as seen in Figure 8A .
  • the foam material is durable enough to withstand the gastric environment and may be manufactured from materials including (but not limited to) rubbers, fluorosilicones, fluoroelastomers, thermoplastic elastomers, or any combinations thereof.
  • the foam body 184 acts as a spring within the stomach, continually placing pressure on the gastric walls, independent of changes in the stomach shape and size. Because the stomach is an ever changing organ (in shape and size) both in the long term (remodeling of the stomach after sustained changes in its environment) and short term (stomach contractions, various body positions), it is difficult to create a single device which can maintain pressure on the gastric walls over a long period of time consistently.
  • the diameter of the foam body 184 needs to be sufficiently large such that even in a large stomach, the foam exerts pressure on the gastric walls. In an exemplary embodiment, the diameter of the foam body 184 is between about 10-20 cm.
  • the foam can be compressed and held in place during implantation and explantation as in Figure 6 .
  • the foam body 184 expands to conform to the approximate shape of the stomach. This pressure on the stomach walls encourages a feeling of fullness, without inhibiting normal passage of food through the GI system.
  • the absolute and relative sizes of the foam body 184 outer surface and inner bore diameters may be adjusted for different patients, with the bore diameter affecting the rate of flow of solid and liquid matter therethrough.
  • the inner bore diameter of the foam body 184 is between about 2-4 cm
  • a still further device 200 that provides a flow-through space is shown in Figures 9 and 9A , and comprises an implantable ear-horn-shaped body 202 with a large bowl-shaped proximal end 204 tapering down in a distal direction along a hollow leg 206 to a hollow spherical pyloric member 208.
  • the hollow leg 206 and pyloric member 208 are both interrupted by a plurality of apertures 210 that permit fluid communication between the inside and the outside of the hollow structures.
  • the device 200 is not an inflated balloon. Rather, the material used provides sufficient stiffness to maintain the ear-horn shape as shown.
  • the device 200 is formed of a flexible material that allows it to be compressed and pre-loading into a delivery tube (not shown) for esophageal insertion into the stomach. Deployment of the device 200 within the stomach cavity permits expansion of the device into the position shown in Figure 9 , with the bowl-shaped proximal end 204 facing the esophagus and the pyloric member 208 located within the pylorus. Device removal is accomplished using a standard grabber down a similar tube which has been inserted down the esophagus, so the entire device can be pulled back into the tube and removed therewith.
  • the diameter and concavity of the bowl-shaped proximal end 204 allows it to contact the stomach cavity walls and intercept food and liquid entering through the esophageal sphincter.
  • the proximal end 204 acts as a detention tray positioned just inside the stomach from the esophageal sphincter that presents a barrier to incoming food bound for the stomach, but which eventually overflows its contents into the stomach.
  • a small drain hole 212 acts as an artificial stoma and permits a limited amount of food and liquid past the proximal end 204 and into the cavity of the body 202. From there, gastric juices mixed with the food particles and begin the process of breaking them down into chyme.
  • the body 202 is sufficiently flexible so that contractions of the stomach muscles are transmitted therethrough.
  • the diameter of the spherical pyloric member 208 is sufficiently large that it cannot pass through the pyloric sphincter.
  • the proximal end 204 contacts the walls around the esophageal junction, and against the cardia.
  • the hollow leg 206 serves as an anti-rotational feature to help hold the device in place, and allow it to return to a normal position as shown, after peristaltic waves in the stomach.
  • an ear-horn-shaped device 200' is configured the same as and works essentially like the device 200 of Figure 9 , except the device is a thinner-walled (hollow) balloon, intended to be saline-filled once inside the stomach. As such, like features will be given the same element numbers.
  • the second embodiment 200' has a tube 214 that extends between the drain hole 212 and an opposite surface of the body 202, on the convex side thereof.
  • food that passes through the drain hole 212 does not enter the interior of the inflated body 202, but instead passes to the opposite side.
  • the tube 214 tethers the bowl-shaped proximal end 204 to the opposite surface of the balloon, so when saline-filled, the concave bowl shape is retained.
  • the amount of food caught by and contained in the concave bowl 204 is far less than can be held in an empty stomach.
  • when food enters the bowl 204 it accumulates and applies pressure to the cardia, thereby stimulating release of satiety-inducing hormones.
  • Deployment of the device 200' within the stomach cavity is similar to the earlier embodiment, but once deployed in the cavity the user inflates the body 202 through a fill valve 216 provided in the concave proximal end 204. Removal of the inflated device 200' is accomplished by inserting a tube down the esophagus, and clippers down the tube. The device 200' can then be clipped to evacuate the saline, and a standard grabber can then be employed to pull the deflated balloon back into the tube for removal therewith.
  • size adjustability is possible by removing or adding saline, whereas the first embodiment may be supplied in a few different sizes.
  • the inflated embodiment 200' is thought to have a more compliant stoma than the non-inflated version 200, so food passage can be somewhat easier.
  • Figures 11-16 illustrate additional intragastric devices that effect cardial stimulation to signal the brain to release the satiety-inducing hormones, which eventually slows eating, resulting in weight loss.
  • These devices feature a detention tray positioned just inside the stomach from the esophageal sphincter that presents a barrier to incoming food bound for the stomach, but which eventually overflows its contents into the stomach.
  • the detention trays Much as prior art gastric bands restrict the free flow of boluses of food into the stomach, the detention trays cause a temporary backup of food at the esophageal/stomach junction, which inevitably contacts the surrounding cardial walls and stimulates satiety.
  • those shown in Figures 11-16 are intended to be transorally placed, without the need for laparoscopic or other surgical assist, and without the need for piercing of tissues to physically anchor the device. Further, these devices are intended to maintain their position without the need for stent-anchoring within the esophagus. Without some type of permanent positioning method, however, migration of a stomach-implanted device can occur, with limited chance of the device ever returning to its intended position. Instead, these devices achieve their “anchoring" by loosely maintaining their position and “springing back" whenever moved.
  • a hollow tether with a springy/stiff consistency and a length spanning the length of the stomach from the pylorus to the cardia, so as to loosely hold the device in position is achieved by way of a hollow tether with a springy/stiff consistency and a length spanning the length of the stomach from the pylorus to the cardia, so as to loosely hold the device in position.
  • the springy stiffness is due to either the use of a fairly stiff material for the tether itself, such a polypropylene, or via a co-extruded spring of various materials (e.g., Nitinol), molded within the lumen walls.
  • Figure 11 shows an intragastric device 300 including a series of elements spaced apart (“daisy-chained") within the stomach cavity and connected by a tether 302 that supports a detention tray 304 just below the esophageal sphincter.
  • the device 300 has a length sufficient to extend substantially the entire length of the stomach cavity from the pyloris to the esophageal/stomach junction and for a distance into the esophagus.
  • the device 300 includes a saline-filled proximal positioning balloon 306, a plurality of intermediate balloons 308, and a pyloric balloon 310, together which support/hold the tether 302 between the lesser and greater curvatures of the stomach.
  • the tether 302 remains spaced from the stomach walls, and is curved to fit the anatomy, generally tracking the greater curvature of the stomach.
  • the balloons 306, 308, 310 can be provided in various configurations, as will be seen with the proximal positioning balloon 306.
  • the volume of the balloons, and the positioning balloon 306 in particular are also space-occupying, similar to prior art spherical bioenteric balloons such as the Orbera® System from Allergan Medical of Irvine, CA.
  • the aggregate volume of the balloons 306, 308, 310 may occupy approximately the same volume (400ml) as the aforementioned Orbera® System, which is proven sufficient to facilitate weight loss.
  • the detention tray 304 is a pliable, shallow conical or bowl-shaped structure with a concave proximal side toward the esophagus.
  • the flexible tether 302 loosely holds the detention tray 304 in place at the proximal end thereof so as to be positioned just below the junction of the esophagus and stomach. That is, the tray 304 is positioned on the tether 302 relative to the pyloric balloon 310 so as to be located adjacent the cardia.
  • the detention tray 304 is preferably not inflatable.
  • the tether 302 projects both distally towards its distal termination at the pyloric balloon 310 and proximally from the tray 304.
  • the proximal end of the tether 304 extends into the lower portion of the esophagus and preferably features a fill valve 312 at its proximal terminus.
  • the fill valve 312 at the proximal terminus of the tether 302 allows saline to be added though a detachable fill tube (not shown) inserted down the esophagus, and includes a self-closing slit to hold the saline inside the device 300. Details of an exemplary fill valve 312 will be provided below with reference to Figures 16A-16C .
  • the length of the tether 302 runs through the tray 304 and though the hollow balloons 306 and 308 to terminate at the pyloric balloon 310.
  • the distal end of the tether 302 is attached, open-ended inside the annular- or donut-shaped pyloric balloon 310 for filling it with saline.
  • the entire series of balloons 306, 308, 310 can therefore be filled after placement within the stomach via the proximal fill valve 312.
  • the proximal end of the tether 302 extending into the esophagus is also intended to help maintain the centered position of the detention tray 304 against the cardia, pressed upwards from the pylorus.
  • the proximal end of the tether 302 may in fact travel downward, loosening the tray intermittently, but the tether shall be of sufficient length to prevent its migration completely out of the esophagus at any time.
  • the total length of the device 300 from the fill valve 312 to the pyloric balloon 310 is between about 35-40 cm when the tether 302 is measured in a straight line.
  • the intermediate balloons 308 are desirably spherical and identical, but they may also be provided with exterior features (e.g. bumps) such as described below, and they may be dissimilar.
  • the twin spherical intermediate balloons 308 are intended to cushion the tether 302 from directly/sharply touching the greater curvature of the stomach.
  • the largest balloon, the proximal positioning balloon 306 features an arcuate, generally semi-circular outer section 320 connected at either end to radial spoke sections 322 that meet in the middle along an axis of the structure through which the tether 302 passes.
  • a shorter radial spoke section 324 extends between the outer section 320 and the convergence of the larger spoke sections 322 in the middle of the balloon 320, and generally extends along a plane that bisects the balloon into two symmetric halves.
  • Two apertures 325 formed between the outer section 320 and the spoke sections 322, 324 permit passage of food therethrough such that the positioning balloon 306 does not present a solid barrier to churning movement of food within the stomach.
  • the positioning balloon 306 as viewed from the side has a gradual taper such that its axial thickness, or height, is greater toward the middle of the balloon where the tether 302 passes than at the outer section 320.
  • the pyloric balloon 310 has a generally spherical outer shape with a lumen 326 extending axially through the middle to create a donut shape.
  • the lumen 326 through the center of the pyloric balloon permits normal egress of food from the stomach into the duodenum.
  • the inflated pyloric balloon 310 cushions against the pylorus without making a tight seal, but intermittently "sealing" nonetheless. This tends to delay gastric emptying.
  • the tether 302 terminates within one side of the axi-symmetric balloon 310 and a cavity formed therein extends around 360° so the balloon may be evenly filled via the tether.
  • Figure 13 is a variation of an intragastric device 330 similar to that shown in Figure 11 .
  • the device 330 includes an elongated curved tether 332 that positions a detention tray 334 below the esophagus, and includes an enlarged positioning balloon 336, a pair of intermediate balloons 338, and a pyloric balloon 340.
  • Figures 14A-14B show details of the device 330 of Figure 13 .
  • the enlarged positioning balloon 336 features a complete outer circular section 342 having a pair of diametric perpendicular spokes 344 defining food passages therebetween and extending across a middle portion through which the tether 332 passes.
  • the complete circular section 342 of the positioning balloon 336 may provide improved "anchoring" of the device 330 within the stomach.
  • the intragastric device 330 is the same as the above-described intragastric device 300.
  • Figure 15 is still further variation of an intragastric device 350 like that of Figure 11 , with a detention tray 352 below the esophagus on a tether 354, but without a proximal positioning balloon.
  • the device 350 still has a pair of intermediate balloons 356 and a distal pyloric balloon 358.
  • FIG. 16A-16C An exemplary fill valve 312 for use with the device 300 of Figures 11 (and also the devices of Figures 13 and 15 ) is shown in Figures 16A-16C .
  • the valve 312 includes an enlarged proximal end 360 which steps down in diameter to a distal insert section 362 that fits tightly within a lumen 364 of the hollow tether 302.
  • a generally inwardly-conical lead-in mouth 370 opens into a retention chamber 372 within the proximal end 360.
  • a slit passage 374 extends through to the distal end of the insert section 362.
  • a fill tube (not shown) has a barbed nipple or other feature that may be forced through the lead-in mouth 370 and captured within the retention chamber 372.
  • Saline under pressure can then be forced through the slit passage 374 and into the lumen 364 of the tether 302. After removal of the fill tube, the slit passage 374 closes up, thus sealing the saline within the device 300 and its daisy-chained balloons.
  • Figures 17A-17B illustrate a still further flow-through intragastric implant 400 in a contracted, delivery configuration
  • Figures 18A-18B illustrate the implant 400 in an expanded, deployed configuration
  • the implant 400 is in the shape of an inflated tube, with an outer tubular wall 402 joined to an inner tubular wall 404 at circular ends 406.
  • a flow-through lumen 408 extends from end to end.
  • the implant 400 may be delivered in a relatively small tube as seen in Figures 17A-17B and then inflated within the stomach to the larger tubular shape of Figures 18A-18B .
  • a fill valve (not shown may be provided in the outer wall 402 or at one of the ends 406.
  • the inflated shape in Figure 18A is relatively short axially and wide in diameter so that it may rotate within the stomach.
  • the axial dimension is between about 5-10 cm, while the outer diameter is between about 4-8 cm, with the low bound of each range coinciding with the low bound of the other range, and vice versa. Uneven exterior surface features such as described below may be added to further provide stimulation. Additionally, the volume of the implant 400 may occupy approximately the same volume (400ml) as the aforementioned Orbera® System, which is proven sufficient to facilitate weight loss
  • the outer surface of the intragastric devices disclosed herein may further include additional uneven surface features such as small rounded bumps or protrusions, quill-like extensions, dimples or recesses, and the like. These features, upon contact with the inner stomach wall of the patient may further trigger hormone release or otherwise aid the patient in feeling full. Such features may be particularly effective for those embodiments which stimulate the cardia.
  • the examples in Figures 19-21 may be applied to any of the various devices and surfaces disclosed herein.
  • Figure 19 illustrates a spherical intragastric device 510 having numerous external protrusions or bumps 512 projecting outward therefrom. These bumps 512 separately contact the inner walls of the stomach, potentially increasing the stimulation to the surrounding satiety-sensing nerves.
  • a plurality of bumps 512 may be equally spaced apart on the outer surface and interspersed with flat portions.
  • the bumps 512 may be of equal heights and diameters, or they may be configured to have different heights and/or diameters. For example, having bumps 512 with different heights and/or diameters may be advantageous for preventing the stomach from adjusting to the bumps.
  • the bumps 512 separately contact the inner walls of the stomach, potentially increasing the stimulation to the surrounding satiety-sensing nerves.
  • an intragastric device 520 formed as a sphere features a multitude of small flagella or quill-like extensions 522 extending outward therefrom.
  • a plurality of extensions 522 may be equally spaced apart.
  • the extensions 522 may be of equal heights and diameters, or they may be configured to have different heights and/or diameters.
  • the extensions 522 may be extremely flexible and may bend when a pressure is exerted on them from the inner stomach wall of the patient.
  • the extensions 522 may be stiffer and might not bend as much when a pressure is exerted on them from the inner stomach wall of the patient.
  • some of the extensions 522 may have a first flexibility while some of the extensions may have a second flexibility.
  • Figure 21 illustrates another example of uneven surface features on an intragastric device 550.
  • the intragastric device 550 is a substantially spherical object with recesses or dimples 555 extending inward from the surface of the intragastric device 550.
  • the intragastric device 550 may be considered to have a surface comprised of recesses 555 and flat portions 560.
  • a plurality of recesses 555 may be equally spaced apart on the outer surface.
  • recesses 555 do not contact each other, and may be of equal heights and diameters.
  • the recesses 555 may employ a thinner wall.
  • the recesses 555 may have a wall thickness of 10 millimeters. With a thinner wall, the recesses 555 may be more susceptible to larger strains.
  • the intragastric device 550 is effectively triggered in the patient's stomach by stomach contractions. These stomach contractions increase the pressure in the intragastric device 550. If one recess 555 is not in contact with the stomach wall, it will deform outward until it comes into contact with the stomach wall.
  • any of the embodiments described herein may utilize materials that improve the efficacy of the device.
  • a number of elastomeric materials may be used including, but not limited to, rubbers, fluorosilicones, fluoroelastomers, thermoplastic elastomers, or any combinations thereof.
  • the materials are desirably selected so as to increase the durability of the device and facilitate implantation of at least six months, and preferably more than 1 year.
  • Material selection may also improve the safety of the device. Some of the materials suggested herein, for example, may allow for a thinner wall thickness and have a lower coefficient of friction than the current device which may aid in the natural passage of the balloon through the GI tract should the device spontaneously deflate.
  • the implantable devices described herein will be subjected to clinical testing in humans.
  • the devices are intended to treat obesity, which is variously defined by different medical authorities.
  • overweight and “obese” are labels for ranges of weight that are greater than what is generally considered healthy for a given height.
  • the terms also identify ranges of weight that have been shown to increase the likelihood of certain diseases and other health problems.
  • Applicants propose implanting the devices as described herein into a clinical survey group of obese patients in order to monitor weight loss.

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  • Health & Medical Sciences (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgery (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Claims (6)

  1. Implant intragastrique passif de traitement de l'obésité (160), comprenant :
    un corps gonflable (161) ayant une longueur suffisante pour s'étendre entre le sphincter oesophagien au niveau d'une extrémité supérieure du corps et le sphincter pylorique au niveau d'une extrémité inférieure du corps après implantation dans l'estomac, et une largeur suffisante pour être en contact avec les parois intérieures de l'estomac lors de la contraction de celui-ci, le corps étant arrondi et légèrement conique de façon à se conformer globalement au volume d'une cavité gastrique d'adulte, le corps comprenant une série de chambres (166) en communication à fluide de façon à pouvoir être gonflées et dégonflées simultanément, dans lequel deux chambres au niveau de l'extrémité supérieure sont séparées par un creux annulaire (163) qui est placé de façon à s'ouvrir vers le sphincter oesophagien, et dans lequel des ouvertures (169) dans le creux annulaire s'ouvrent vers un canal d'écoulement central qui s'étend du creux annulaire à l'extrémité inférieure du corps, et dans lequel des chambres entourent le canal d'écoulement central, dans lequel les chambres entourant respectivement le canal d'écoulement central constituent une partie de la série de chambres,
    l'implant étant formé d'un matériau qui lui permet d'être comprimé dans une configuration d'acheminement sensiblement linéaire et qui résistera à la dégradation sur une période d'au moins six mois dans l'estomac.
  2. Implant selon la revendication 1, dans lequel le canal d'écoulement central a une section transversale en étoile.
  3. Implant selon la revendication 1, comprenant en outre une pluralité de rainures circonférentielles (167) s'étendant autour du corps et entre des chambres adjacentes, et des passages radiaux (170) raccordant les rainures circonférentielles au canal d'écoulement central.
  4. Implant selon la revendication 1, dans lequel les chambres diminuent progressivement de diamètre des extrémités supérieure à inférieure du corps.
  5. Implant selon la revendication 1, dans lequel le corps comprend une extrémité supérieure arrondie qui imite la forme du cardia avoisinant et définit une chambre proximale dans celui-ci.
  6. Implant selon l'une quelconque des revendications précédentes, dans lequel, outre une chambre (166) au niveau de l'extrémité supérieure (162), le corps (161) a trois chambres annulaires (166) délimitées par des rainures circonférentielles extérieures (167) et entourant le canal d'écoulement central (168), qui est un canal d'écoulement interne, globalement longitudinal, dans lequel les trois chambres (166) diminuent progressivement de diamètre de l'extrémité supérieure à inférieure du dispositif (160).
EP11773973.0A 2010-10-19 2011-10-18 Implants intragastriques remplisseurs d'espace à écoulement de fluide Not-in-force EP2629712B1 (fr)

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WO2012054413A2 (fr) 2012-04-26
WO2012054413A3 (fr) 2012-06-21
ES2594484T3 (es) 2016-12-20
EP2629712A2 (fr) 2013-08-28
US9095405B2 (en) 2015-08-04
WO2012054413A4 (fr) 2012-08-09

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